A. Field of the Invention
The embodiments of the present invention relate to a treatment for obesity, and more particularly, the embodiments of the present invention relate to a multi-method and multi-apparatus for treating obesity.
B. Description of the Prior Art
In the published medical literature, there are a significant number of patients who experience adverse gastrointestinal complaints in the period immediately after the deployment of an intragastric balloon. In this experience, all patients are treated with one specific model and size of balloon.
Thus, there exists a need for an intragastric balloon wherein both the geometry or shape of the balloon, as well as the volume of the balloon, are components that can be manipulated to enhance the therapeutic effect and to minimize complications.
In the published medical literature, intragastric balloons are placed in a deflated form and than inflated once in the stomach. The only material holding the balloons in their active shape is either air, liquid, or both. It is possible for these substances to leak out of the balloon causing the balloon to deflate and fail.
Thus, there exists a need for an intragastric balloons including a skeleton of metal struts that strengthen the balloon structure and prevent premature balloon failure, which could lead to a loss of therapeutic effect in obesity and can also lead to small bowel obstruction or gastric outlet obstruction.
In the published medical literature, intragastric balloons have been associated with the complication of irritation of the lining of the stomach (gastritis) and gastric ulceration. Considering the example of the intragastric balloon already patented by the instant inventors as U.S. Pat. No. 4,694,827, this complication was contemplated and a solution offered by using an intragastric balloon having protrusions and channels.
Non-compliance with therapeutic medications is a well known clinical problem interfering with good patient outcomes. Many different solutions have been attempted to deal with this problem, and to date, none have been completely satisfactory.
In the medical literature, damage to the lining of the stomach has been a major complication of intragastric balloon therapy. In many cases, severe damage, such as ulceration, may require removal of the balloon. Alternatively, there are many cases of patients with symptoms that might be related to the intragastric balloon, but might also be related to intercurrent viral illnesses, food poisoning, or milder complications of balloon therapy, not necessitating balloon extraction. In current practice, patients would undergo an upper endoscopy to assess the situation.
There are a multitude of methods purported to treat obesity in humans. Among the most effective of these methods are surgical techniques that alter the volume of the stomach available to receive food from the mouth and esophagus. The most popular of these surgical techniques is often referred to as a (Roux en Y) gastric bypass procedure. The gastric bypass is thought to work by limiting the amount of food that can be ingested at one time, although it may also alter gastrointestinal hormones and decrease the appetite.
Numerous innovations for inflatable medical devices have been provided in the prior art, which will be described below in chronological order to show advancement in the art, and which is incorporated herein by reference thereto. Even though these innovations may be suitable for the specific individual purposes to which they address, however, they differ from the present invention in that they do not teach a multi-method and multi-apparatus for treating obesity.
(1) U.S. Pat. No. 766,336 to Farrington.
U.S. Pat. No. 766,336 issued to Farrington on Aug. 2, 1904 teaches a device including a fluid-supply tube having a plurality of parallel slots and springs arranged within the tube and adapted to be partly projected through the slots. The springs have their inner ends secured to the tube. An adjustable member is secured to the outer ends of the springs. Elastic covers extend around that portion of the springs projecting through the slots.
(2) U.S. Pat. No. 797,676 to Flowers.
U.S. Pat. No. 797,676 issued to Flowers on Aug. 22, 1905 teaches a syringe including a nozzle having outlets and an expandable sack enveloping the nozzle, having outlets, and formed with longitudinal ribs stiffening and reinforcing the sack in the direction of its length and admitting of its diametrical expansion.
(3) U.S. Pat. No. 4,416,267 to Garren et al.
U.S. Pat. No. 4,416,267 issued to Garren et al. on Nov. 22, 1983 in class 128 and subclass 1 R teaches a stomach insert for treating obesity in humans by reducing the stomach volume, which includes a flexible torus-shaped inflatable balloon having a central opening extending therethrough. At least a portion of the balloon has a self-sealing substance to facilitate puncture thereof with a needle for inflating the balloon and sealing of the puncture upon removal of the needle. The method includes positioning the balloon inside the stomach of the person being treated for obesity so as to reduce the stomach volume.
(4) U.S. Pat. No. 4,694,827 to Weiner et al.
U.S. Pat. No. 4,694,827 issued to Weiner et al. on Sep. 22, 1987 in class 128 and subclass 303 R teaches generally, a balloon insertable and inflatable in the stomach to deter ingestion of food and having, when inflated, a plurality of smooth-surfaced convex protrusions disposed to permit engagement of the stomach wall by the balloon only at spaced localities for minimizing mechanical trauma of the stomach wall by the balloon.
Specifically, as shown in FIG. 1, which is a diagrammatic side elevational view in partial section of a prior art balloon fully expanded within a stomach, a balloon 10 being flexible-walled, imperforate, air-inflatable, and insertable and inflatable within the stomach 12 of a human 14 or animal 16 to deter ingestion of food 18 by occupying a substantial portion 20 of the volume 22 of the stomach 12 is taught. The balloon 10 has a plurality of wall portions 24 forming protrusions 26 that are smooth-surfaced, convex, and outward when inflated. The protrusions 26 are distributed around the balloon 10 and cooperatively define a plurality of channels 28 that are outwardly open for passage of fluent material 30 between the outer surface 32 of the balloon 10 and the wall 34 of the stomach 12, and are shaped and disposed to permit engagement of the wall 34 of the stomach 12 by the balloon 10 only at spaced localities 36 so as to maintain a substantial portion 38 of the wall 34 of the stomach 12 away from contact with the balloon 10 for minimizing complications due to mechanical trauma of the balloon 10 against the wall 34 of the stomach 12.
The protrusions 26 and the channels 28 minimize physical contact with the wall 34 of the stomach 12 and stimulate cytoprotection. Cytoprotection is an innate mechanism of preservation of the stomach 12 from adverse effects of a harsh environment of a gastric lumen.
It is apparent that numerous innovations for inflatable medical devices have been provided in the prior art that are adapted to be used. Furthermore, even though these innovations may be suitable for the specific individual purposes to which they address, however, they would not be suitable for the purposes of the embodiments of the present invention as heretofore described, namely, a multi-method and multi-apparatus for treating obesity.